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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K833867
Device Name PAREMA K BAND NON-STERILE
Applicant
Mark One Healthcare Products
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Mark One Healthcare Products
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
EFQ  
Date Received11/07/1983
Decision Date 01/27/1984
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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